Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Bir… (NCT06537778) | Clinical Trial Compass
CompletedNot Applicable
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
China334 participantsStarted 2018-01-03
Plain-language summary
After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (i) Viable singleton gestation between 14 0/7 and 23 6/7 weeks of gestation.
* (ii) Previous history of miscarriage or preterm labor in mid-pregnancy.
* (iii) Transvaginal ultrasound examination showed that the cervix is 25mm or less at gestations less than 24 weeks.
Exclusion Criteria:
* (i) Women with uterine contractions.
* (ii) Vaginal bleeding.
* (iii) Symptoms of chorioamnionitis.
* (iv) Medically indicated PTB (severe preeclampsia, placental abruption, preterm premature rupture of membranes).
* (v) Major structural or chromosomal abnormalities.
* (vi) Contraindication to atosiban.
* (vii) Had received atosiban or any tocolytic agents within 7 days before their presentation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of sPTB
Timeframe: up to 34 weeks
Trial details
NCT IDNCT06537778
SponsorChildren's Hospital of Chongqing Medical University